CN1642570A - 含吸因子ⅷ的稳定药物组合物 - Google Patents
含吸因子ⅷ的稳定药物组合物 Download PDFInfo
- Publication number
- CN1642570A CN1642570A CNA038069911A CN03806991A CN1642570A CN 1642570 A CN1642570 A CN 1642570A CN A038069911 A CNA038069911 A CN A038069911A CN 03806991 A CN03806991 A CN 03806991A CN 1642570 A CN1642570 A CN 1642570A
- Authority
- CN
- China
- Prior art keywords
- leu
- ser
- val
- gly
- glu
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Granted
Links
- 229960000301 factor viii Drugs 0.000 title abstract description 15
- 239000008194 pharmaceutical composition Substances 0.000 title abstract description 12
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims abstract description 40
- 239000000203 mixture Substances 0.000 claims abstract description 28
- 239000007787 solid Substances 0.000 claims abstract description 24
- 150000001413 amino acids Chemical class 0.000 claims abstract description 20
- 239000011780 sodium chloride Substances 0.000 claims abstract description 20
- UXVMQQNJUSDDNG-UHFFFAOYSA-L Calcium chloride Chemical compound [Cl-].[Cl-].[Ca+2] UXVMQQNJUSDDNG-UHFFFAOYSA-L 0.000 claims abstract description 16
- 239000001110 calcium chloride Substances 0.000 claims abstract description 16
- 229910001628 calcium chloride Inorganic materials 0.000 claims abstract description 16
- 238000004108 freeze drying Methods 0.000 claims abstract description 15
- XLYOFNOQVPJJNP-UHFFFAOYSA-N water Chemical compound O XLYOFNOQVPJJNP-UHFFFAOYSA-N 0.000 claims abstract description 15
- CZMRCDWAGMRECN-UGDNZRGBSA-N Sucrose Chemical compound O[C@H]1[C@H](O)[C@@H](CO)O[C@@]1(CO)O[C@@H]1[C@H](O)[C@@H](O)[C@H](O)[C@@H](CO)O1 CZMRCDWAGMRECN-UGDNZRGBSA-N 0.000 claims abstract description 14
- 229930006000 Sucrose Natural products 0.000 claims abstract description 14
- 239000005720 sucrose Substances 0.000 claims abstract description 14
- 239000000872 buffer Substances 0.000 claims abstract description 11
- 239000001509 sodium citrate Substances 0.000 claims abstract description 11
- 239000004094 surface-active agent Substances 0.000 claims abstract description 11
- HRXKRNGNAMMEHJ-UHFFFAOYSA-K trisodium citrate Chemical compound [Na+].[Na+].[Na+].[O-]C(=O)CC(O)(CC([O-])=O)C([O-])=O HRXKRNGNAMMEHJ-UHFFFAOYSA-K 0.000 claims abstract description 11
- 229940038773 trisodium citrate Drugs 0.000 claims abstract description 11
- 239000007788 liquid Substances 0.000 claims abstract description 5
- 239000008215 water for injection Substances 0.000 claims abstract description 5
- 239000012895 dilution Substances 0.000 claims abstract 2
- 238000010790 dilution Methods 0.000 claims abstract 2
- 102100022641 Coagulation factor IX Human genes 0.000 claims description 50
- 108010076282 Factor IX Proteins 0.000 claims description 50
- 229960004222 factor ix Drugs 0.000 claims description 50
- 239000002131 composite material Substances 0.000 claims description 19
- 235000001014 amino acid Nutrition 0.000 claims description 17
- 239000003814 drug Substances 0.000 claims description 17
- 230000008521 reorganization Effects 0.000 claims description 13
- 239000000243 solution Substances 0.000 claims description 11
- 239000000244 polyoxyethylene sorbitan monooleate Substances 0.000 claims description 7
- 235000010482 polyoxyethylene sorbitan monooleate Nutrition 0.000 claims description 7
- 229920000053 polysorbate 80 Polymers 0.000 claims description 7
- 229940068968 polysorbate 80 Drugs 0.000 claims description 7
- 229960000027 human factor ix Drugs 0.000 claims description 6
- 229920000136 polysorbate Polymers 0.000 claims description 6
- 229950008882 polysorbate Drugs 0.000 claims description 5
- -1 (methylol) methyl Chemical group 0.000 claims description 4
- BAVYZALUXZFZLV-UHFFFAOYSA-N mono-methylamine Natural products NC BAVYZALUXZFZLV-UHFFFAOYSA-N 0.000 claims description 3
- 239000000693 micelle Substances 0.000 claims description 2
- 125000003275 alpha amino acid group Chemical group 0.000 claims 1
- 102000001690 Factor VIII Human genes 0.000 abstract description 14
- 108010054218 Factor VIII Proteins 0.000 abstract description 13
- 239000008223 sterile water Substances 0.000 abstract 1
- DHMQDGOQFOQNFH-UHFFFAOYSA-N Glycine Chemical compound NCC(O)=O DHMQDGOQFOQNFH-UHFFFAOYSA-N 0.000 description 168
- 235000002639 sodium chloride Nutrition 0.000 description 16
- 102220369447 c.1352G>A Human genes 0.000 description 14
- 102220023257 rs387907546 Human genes 0.000 description 8
- 101000911390 Homo sapiens Coagulation factor VIII Proteins 0.000 description 7
- 102220369446 c.1274G>A Human genes 0.000 description 7
- 102220369445 c.668T>C Human genes 0.000 description 7
- 238000012360 testing method Methods 0.000 description 7
- WCUXLLCKKVVCTQ-UHFFFAOYSA-M Potassium chloride Chemical compound [Cl-].[K+] WCUXLLCKKVVCTQ-UHFFFAOYSA-M 0.000 description 6
- 238000009472 formulation Methods 0.000 description 6
- 238000000034 method Methods 0.000 description 6
- 102220023256 rs387907547 Human genes 0.000 description 6
- 239000002736 nonionic surfactant Substances 0.000 description 5
- 241000196324 Embryophyta Species 0.000 description 4
- 239000007983 Tris buffer Substances 0.000 description 4
- 238000004458 analytical method Methods 0.000 description 4
- 230000000694 effects Effects 0.000 description 4
- 102000057593 human F8 Human genes 0.000 description 4
- 230000004048 modification Effects 0.000 description 4
- 238000012986 modification Methods 0.000 description 4
- 238000002360 preparation method Methods 0.000 description 4
- 102220023258 rs387907548 Human genes 0.000 description 4
- 102000009027 Albumins Human genes 0.000 description 3
- 108010088751 Albumins Proteins 0.000 description 3
- 102100026735 Coagulation factor VIII Human genes 0.000 description 3
- RVGRUAULSDPKGF-UHFFFAOYSA-N Poloxamer Chemical compound C1CO1.CC1CO1 RVGRUAULSDPKGF-UHFFFAOYSA-N 0.000 description 3
- 239000007864 aqueous solution Substances 0.000 description 3
- KRKNYBCHXYNGOX-UHFFFAOYSA-N citric acid Chemical compound OC(=O)CC(O)(C(O)=O)CC(O)=O KRKNYBCHXYNGOX-UHFFFAOYSA-N 0.000 description 3
- 239000012141 concentrate Substances 0.000 description 3
- 150000002016 disaccharides Chemical class 0.000 description 3
- 239000011363 dried mixture Substances 0.000 description 3
- 238000002347 injection Methods 0.000 description 3
- 239000007924 injection Substances 0.000 description 3
- 150000002772 monosaccharides Chemical class 0.000 description 3
- 229960000502 poloxamer Drugs 0.000 description 3
- 229920001983 poloxamer Polymers 0.000 description 3
- 239000001103 potassium chloride Substances 0.000 description 3
- 235000011164 potassium chloride Nutrition 0.000 description 3
- 238000002415 sodium dodecyl sulfate polyacrylamide gel electrophoresis Methods 0.000 description 3
- 230000000087 stabilizing effect Effects 0.000 description 3
- 230000001954 sterilising effect Effects 0.000 description 3
- 238000004659 sterilization and disinfection Methods 0.000 description 3
- LENZDBCJOHFCAS-UHFFFAOYSA-N tris Chemical compound OCC(N)(CO)CO LENZDBCJOHFCAS-UHFFFAOYSA-N 0.000 description 3
- 108010074860 Factor Xa Proteins 0.000 description 2
- HNDVDQJCIGZPNO-YFKPBYRVSA-N L-histidine Chemical compound OC(=O)[C@@H](N)CC1=CN=CN1 HNDVDQJCIGZPNO-YFKPBYRVSA-N 0.000 description 2
- 239000003963 antioxidant agent Substances 0.000 description 2
- 230000003078 antioxidant effect Effects 0.000 description 2
- 239000012530 fluid Substances 0.000 description 2
- 239000012634 fragment Substances 0.000 description 2
- 238000002523 gelfiltration Methods 0.000 description 2
- 238000004128 high performance liquid chromatography Methods 0.000 description 2
- HNDVDQJCIGZPNO-UHFFFAOYSA-N histidine Natural products OC(=O)C(N)CC1=CN=CN1 HNDVDQJCIGZPNO-UHFFFAOYSA-N 0.000 description 2
- 229940099816 human factor vii Drugs 0.000 description 2
- 238000004519 manufacturing process Methods 0.000 description 2
- 102000004169 proteins and genes Human genes 0.000 description 2
- 108090000623 proteins and genes Proteins 0.000 description 2
- 108010025139 recombinant factor VIII SQ Proteins 0.000 description 2
- 230000009467 reduction Effects 0.000 description 2
- 238000003998 size exclusion chromatography high performance liquid chromatography Methods 0.000 description 2
- QFVHZQCOUORWEI-UHFFFAOYSA-N 4-[(4-anilino-5-sulfonaphthalen-1-yl)diazenyl]-5-hydroxynaphthalene-2,7-disulfonic acid Chemical compound C=12C(O)=CC(S(O)(=O)=O)=CC2=CC(S(O)(=O)=O)=CC=1N=NC(C1=CC=CC(=C11)S(O)(=O)=O)=CC=C1NC1=CC=CC=C1 QFVHZQCOUORWEI-UHFFFAOYSA-N 0.000 description 1
- TYMLOMAKGOJONV-UHFFFAOYSA-N 4-nitroaniline Chemical compound NC1=CC=C([N+]([O-])=O)C=C1 TYMLOMAKGOJONV-UHFFFAOYSA-N 0.000 description 1
- 102000004506 Blood Proteins Human genes 0.000 description 1
- 108010017384 Blood Proteins Proteins 0.000 description 1
- VMQMZMRVKUZKQL-UHFFFAOYSA-N Cu+ Chemical compound [Cu+] VMQMZMRVKUZKQL-UHFFFAOYSA-N 0.000 description 1
- 108010023321 Factor VII Proteins 0.000 description 1
- 239000004471 Glycine Substances 0.000 description 1
- 208000031220 Hemophilia Diseases 0.000 description 1
- 208000009292 Hemophilia A Diseases 0.000 description 1
- 235000003140 Panax quinquefolius Nutrition 0.000 description 1
- 240000005373 Panax quinquefolius Species 0.000 description 1
- 229920003171 Poly (ethylene oxide) Polymers 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 241001323319 Psen Species 0.000 description 1
- 241000700605 Viruses Species 0.000 description 1
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 238000012661 block copolymerization Methods 0.000 description 1
- 230000023555 blood coagulation Effects 0.000 description 1
- 235000011148 calcium chloride Nutrition 0.000 description 1
- 159000000007 calcium salts Chemical class 0.000 description 1
- 238000006555 catalytic reaction Methods 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 239000003593 chromogenic compound Substances 0.000 description 1
- 229920001577 copolymer Polymers 0.000 description 1
- 230000002950 deficient Effects 0.000 description 1
- 239000003599 detergent Substances 0.000 description 1
- 238000007865 diluting Methods 0.000 description 1
- 201000010099 disease Diseases 0.000 description 1
- 208000037265 diseases, disorders, signs and symptoms Diseases 0.000 description 1
- 238000001962 electrophoresis Methods 0.000 description 1
- 238000005516 engineering process Methods 0.000 description 1
- 230000005284 excitation Effects 0.000 description 1
- 238000002474 experimental method Methods 0.000 description 1
- 229940027029 hemofil Drugs 0.000 description 1
- 230000006872 improvement Effects 0.000 description 1
- 239000012678 infectious agent Substances 0.000 description 1
- 238000007918 intramuscular administration Methods 0.000 description 1
- 150000002500 ions Chemical class 0.000 description 1
- 229940047434 kogenate Drugs 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 229940005755 monoclate Drugs 0.000 description 1
- 229920000620 organic polymer Polymers 0.000 description 1
- 229910052760 oxygen Inorganic materials 0.000 description 1
- 239000001301 oxygen Substances 0.000 description 1
- 239000000825 pharmaceutical preparation Substances 0.000 description 1
- 238000005375 photometry Methods 0.000 description 1
- 210000002381 plasma Anatomy 0.000 description 1
- 238000002264 polyacrylamide gel electrophoresis Methods 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 238000006116 polymerization reaction Methods 0.000 description 1
- 229920001451 polypropylene glycol Polymers 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 235000018102 proteins Nutrition 0.000 description 1
- 108010012557 prothrombin complex concentrates Proteins 0.000 description 1
- 229940047431 recombinate Drugs 0.000 description 1
- 150000003839 salts Chemical class 0.000 description 1
- 230000006641 stabilisation Effects 0.000 description 1
- 238000013112 stability test Methods 0.000 description 1
- 239000003381 stabilizer Substances 0.000 description 1
- 230000000638 stimulation Effects 0.000 description 1
- 238000007920 subcutaneous administration Methods 0.000 description 1
- 239000000126 substance Substances 0.000 description 1
- 239000003643 water by type Substances 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/14—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles
- A61K9/19—Particulate form, e.g. powders, Processes for size reducing of pure drugs or the resulting products, Pure drug nanoparticles lyophilised, i.e. freeze-dried, solutions or dispersions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K38/00—Medicinal preparations containing peptides
- A61K38/16—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof
- A61K38/17—Peptides having more than 20 amino acids; Gastrins; Somatostatins; Melanotropins; Derivatives thereof from animals; from humans
- A61K38/36—Blood coagulation or fibrinolysis factors
- A61K38/37—Factors VIII
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/16—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite containing nitrogen, e.g. nitro-, nitroso-, azo-compounds, nitriles, cyanates
- A61K47/18—Amines; Amides; Ureas; Quaternary ammonium compounds; Amino acids; Oligopeptides having up to five amino acids
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/06—Organic compounds, e.g. natural or synthetic hydrocarbons, polyolefins, mineral oil, petrolatum or ozokerite
- A61K47/26—Carbohydrates, e.g. sugar alcohols, amino sugars, nucleic acids, mono-, di- or oligo-saccharides; Derivatives thereof, e.g. polysorbates, sorbitan fatty acid esters or glycyrrhizin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K9/00—Medicinal preparations characterised by special physical form
- A61K9/0012—Galenical forms characterised by the site of application
- A61K9/0019—Injectable compositions; Intramuscular, intravenous, arterial, subcutaneous administration; Compositions to be administered through the skin in an invasive manner
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61P—SPECIFIC THERAPEUTIC ACTIVITY OF CHEMICAL COMPOUNDS OR MEDICINAL PREPARATIONS
- A61P7/00—Drugs for disorders of the blood or the extracellular fluid
- A61P7/04—Antihaemorrhagics; Procoagulants; Haemostatic agents; Antifibrinolytic agents
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61K—PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES
- A61K47/00—Medicinal preparations characterised by the non-active ingredients used, e.g. carriers or inert additives; Targeting or modifying agents chemically bound to the active ingredient
- A61K47/02—Inorganic compounds
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Chemical & Material Sciences (AREA)
- Medicinal Chemistry (AREA)
- Pharmacology & Pharmacy (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Engineering & Computer Science (AREA)
- Epidemiology (AREA)
- Bioinformatics & Cheminformatics (AREA)
- General Chemical & Material Sciences (AREA)
- Chemical Kinetics & Catalysis (AREA)
- Hematology (AREA)
- Proteomics, Peptides & Aminoacids (AREA)
- Oil, Petroleum & Natural Gas (AREA)
- Immunology (AREA)
- Gastroenterology & Hepatology (AREA)
- Zoology (AREA)
- Molecular Biology (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Organic Chemistry (AREA)
- Diabetes (AREA)
- Dermatology (AREA)
- Biochemistry (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Medicinal Preparation (AREA)
- Peptides Or Proteins (AREA)
Abstract
Description
具有序列SEQ.ID.NO.1的修饰的猪因子VIII | 800猪单位/ml |
植物来源的聚山梨醇酯80 | 0.01%v/v |
氯化钙 | 2mM |
蔗糖 | 11.7mM |
氯化钠 | 0.3M |
柠檬酸三钠 | 10mM |
Tris缓冲液 | 10mM |
pH | 7.0 |
具有序列SEQ.ID.NO.1的修饰的猪因子VIII | 400猪单位/ml |
植物来源的聚山梨醇酯80 | 0.002%v/v |
氯化钙 | 2mM |
蔗糖 | 11.7mM |
氯化钠 | 0.3M |
柠檬酸三钠 | 10mM |
Tris缓冲液 | 10mM |
pH | 7.0 |
血浆来源的猪因子VIII | 100猪单位/ml |
植物来源的聚山梨醇酯80 | 0.01%v/v |
氯化钙 | 2mM |
蔗糖 | 11.7mM |
氯化钠 | 0.3M |
柠檬酸三钠 | 10mM |
Tris缓冲液 | 10mM |
pH | 7.0 |
Claims (10)
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CN201210563117.1A CN103006540B (zh) | 2002-03-26 | 2003-03-26 | 含有因子viii的稳定药物组合物 |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
GB0207092.8 | 2002-03-26 | ||
GBGB0207092.8A GB0207092D0 (en) | 2002-03-26 | 2002-03-26 | Stable pharmaceutical composition containing factor VIII |
PCT/GB2003/001297 WO2003080108A1 (en) | 2002-03-26 | 2003-03-26 | Stable pharmaceutical composition containing factor viii |
Related Child Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201210563117.1A Division CN103006540B (zh) | 2002-03-26 | 2003-03-26 | 含有因子viii的稳定药物组合物 |
Publications (2)
Publication Number | Publication Date |
---|---|
CN1642570A true CN1642570A (zh) | 2005-07-20 |
CN1642570B CN1642570B (zh) | 2013-01-09 |
Family
ID=9933726
Family Applications (2)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN038069911A Expired - Lifetime CN1642570B (zh) | 2002-03-26 | 2003-03-26 | 含有因子ⅷ的稳定药物组合物 |
CN201210563117.1A Expired - Lifetime CN103006540B (zh) | 2002-03-26 | 2003-03-26 | 含有因子viii的稳定药物组合物 |
Family Applications After (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CN201210563117.1A Expired - Lifetime CN103006540B (zh) | 2002-03-26 | 2003-03-26 | 含有因子viii的稳定药物组合物 |
Country Status (27)
Country | Link |
---|---|
US (1) | US7790680B2 (zh) |
EP (2) | EP1490095B1 (zh) |
JP (4) | JP2005530714A (zh) |
KR (1) | KR20040093482A (zh) |
CN (2) | CN1642570B (zh) |
AR (1) | AR039123A1 (zh) |
AT (1) | ATE477814T1 (zh) |
AU (1) | AU2003217030B2 (zh) |
BR (1) | BR0308442A (zh) |
CA (1) | CA2480226C (zh) |
DE (1) | DE60333825D1 (zh) |
DK (1) | DK1490095T3 (zh) |
ES (1) | ES2350337T3 (zh) |
GB (1) | GB0207092D0 (zh) |
HK (2) | HK1080713A1 (zh) |
HR (1) | HRP20040882B1 (zh) |
IL (2) | IL163849A0 (zh) |
IS (1) | IS7458A (zh) |
MX (1) | MXPA04009275A (zh) |
MY (1) | MY149831A (zh) |
NO (1) | NO328450B1 (zh) |
NZ (1) | NZ535032A (zh) |
PL (1) | PL208009B1 (zh) |
PT (1) | PT1490095E (zh) |
RU (1) | RU2314825C2 (zh) |
TW (1) | TWI285106B (zh) |
WO (1) | WO2003080108A1 (zh) |
Cited By (1)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
CN107049964A (zh) * | 2008-09-03 | 2017-08-18 | 奥克塔法马股份有限公司 | 重组制备的因子viii的新型保护组合物 |
Families Citing this family (18)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7560107B2 (en) | 1996-06-26 | 2009-07-14 | Emory University | Modified factor VIII |
AU2003285075B2 (en) * | 2002-10-29 | 2009-10-29 | Durect Corporation | Stabilized, solid-state polypeptide particles |
US7485291B2 (en) | 2003-06-03 | 2009-02-03 | Cell Genesys, Inc. | Compositions and methods for generating multiple polypeptides from a single vector using a virus derived peptide cleavage site, and uses thereof |
JP4644663B2 (ja) | 2003-06-03 | 2011-03-02 | セル ジェネシス インコーポレイテッド | ペプチド開裂部位を用いた単一ベクターからの組換えポリペプチドの高められた発現のための構成と方法 |
JP2007534633A (ja) * | 2003-11-10 | 2007-11-29 | アライバ−プロメティック インコーポレイティド | ヒト・アルファ1−抗トリプシン製剤 |
EP1750733B1 (en) | 2004-05-03 | 2013-12-11 | Emory University | METHOD OF ADMINISTERING PORCINE B-DOMAINLESS fVIII |
AU2009240026B2 (en) | 2008-04-21 | 2014-05-29 | Novo Nordisk Health Care Ag | Dry transglutaminase composition |
EP2113564A1 (en) | 2008-05-01 | 2009-11-04 | Arecor Limited | Protein formulation |
AU2009284113B2 (en) | 2008-08-21 | 2015-05-14 | Octapharma Ag | Recombinantly produced human factor VIII and IX |
BRPI0921429B1 (pt) | 2008-11-07 | 2022-07-12 | Takeda Pharmaceutical Company Limited | Formulação farmacêutica liofilizada estável, e, método para preparar um fator liofilizado estável |
GB0915480D0 (en) * | 2009-09-04 | 2009-10-07 | Arecor Ltd | Stable formulation of factor viii |
DK2635297T3 (da) | 2010-11-05 | 2019-05-06 | Baxalta GmbH | En ny variant af antihæmofil faktor viii, der har en øget specifik aktivitet |
JP2016518321A (ja) * | 2013-03-15 | 2016-06-23 | バイエル・ヘルスケア・エルエルシーBayer HealthCare LLC | 組み換え因子viii配合物 |
JP6330026B2 (ja) | 2013-03-15 | 2018-05-23 | バイオベラティブ セラピューティクス インコーポレイテッド | 第viii因子ポリペプチド製剤 |
PL3177317T3 (pl) | 2014-08-04 | 2020-07-27 | Csl Limited | Formulacja czynnika viii |
EP3207936B1 (en) * | 2014-11-18 | 2021-04-21 | Shionogi & Co., Ltd. | Stable peptide composition |
CN114072420B (zh) | 2019-07-04 | 2024-06-11 | 康诺贝林伦瑙有限公司 | 用于增加凝血因子viii的体外稳定性的截短的血管性血友病因子(vwf) |
US20220380439A1 (en) | 2020-11-09 | 2022-12-01 | Takeda Pharmaceutical Company Limited | Purification of fviii from plasma using silicon oxide adsorption |
Family Cites Families (19)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
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KR100303872B1 (ko) | 1992-10-02 | 2001-11-22 | 크리스터 발스트룀, 프레드릭 베르그, 하랄트 알름 | 응고인자ⅷ제형을포함하는조성물,이것의제조방법및안정화제로서의계면활성제의사용방법 |
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Cited By (3)
Publication number | Priority date | Publication date | Assignee | Title |
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CN107049964A (zh) * | 2008-09-03 | 2017-08-18 | 奥克塔法马股份有限公司 | 重组制备的因子viii的新型保护组合物 |
CN107050437A (zh) * | 2008-09-03 | 2017-08-18 | 奥克塔法马股份有限公司 | 重组制备的因子viii的新型保护组合物 |
CN107049964B (zh) * | 2008-09-03 | 2020-06-02 | 奥克塔法马股份有限公司 | 重组制备的因子viii的新型保护组合物 |
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